Senior Clinical Research Coordinator and Project Manager
Company: Stanford Medicine
Location: Santa Clara
Posted on: May 10, 2022
Stanford University is seeking a Clinical Research Coordinator 2
(CRC2) project manager to join the Department of Radiology within
the School of Medicine.
Stanford Radiology has been among the top ten NIH-funded radiology
departments each year since 2005, including drug and devise studies
from phase I to IV. The Department of Radiology takes on a unique
position within the School of Medicine. It includes a wide area of
modalities and disease groups and collaborates with numerous
clinicians and researchers in other departments to develop improved
scientific, diagnostic, and therapeutic applications.
We are seeking a CRC2-PProject Manager to help us enact our mission
to reduce disease through comprehensive research, treatment,
education, and outreach programs. The CRC2-project manager will be
working with an unparalleled leading-edge community of faculty and
staff who are fundamentally changing the world of health care.
Candidates need to demonstrate excellent CRC2 skills, outstanding
communication, and organizational skills, and attention to detail
to work independently on projects and clinical trials across a wide
range of diseases. The CRC2-project manager will work in a dynamic
atmosphere within and with a multifaceted team of fellow
coordinators and physicians, scientists, technologists, nurses, and
research fellows. Outstanding communication and organizational
skills and attention to detail are required in a successful
candidate. The coordinator will be responsible for ensuring
compliance with federal, state, local, and sponsor regulations and
work under the direction of their manager.
- The CRC2 project manager will serve as a liaison between
sponsor and investigators and is the primary point person for all
new study startups in Radiology.
- Collaborate with staff and principal investigators to develop
study budgets for clinical trials (e.g., trials with a large number
of participants, high profile industry trials) within the
- The CRC2 project manager will coordinate all logistical aspects
of a new project.
- The CRC2 project manager will instruct CRCAs on new
- The CRC2 project manager will be responsible for monitoring
data collection for clinical trials. More specifically, help
transfer all ongoing and future studies to secure data systems such
as RedCap to align with the School of Medicine data security
- For clinical trials, the CRC2 project manager will delegate
data tasks to CRCAs in the group and is therefore responsible for
the oversight of those tasks.
- This position will perform regular internal auditing of
clinical trial documentation and compliance with appropriate
regulatory agencies, such as the FDA and NRC.
- In cases of non-compliance found on internal audit, this
position will work with the Principal Investigator to develop a
corrective action plan and monitor adherence to that plan.
- Prepare and track study invoices to sponsors and study subject
- This position will work hand-in-hand with the Clinical Trials
and Translational Research Manager and the Translational Research
Steering Committee to identify key challenges in clinical trials /
clinical translational research and recommend and implement
improvements to the Department Clinical Trials and Translation
capabilities and processes.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor's degree in a related field and two years of
experience in clinical research, or an equivalent combination of
education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience with research protocols and regulatory or governing
bodies, which include HIPAA and FDA regulations, Institutional
Review Board requirements, Scientific Review Committee, and Good
- Relevant work experience - i.e., in clinical research, device
development, pharmaceutical industry etc.
- Demonstrated ability to establish priorities, manage shifting
priorities, and handle numerous time-sensitive projects with
- Demonstrated experience working independently and as part of a
- Excellent interpersonal, written and oral communication
- Proficiency with Microsoft Office and database
CERTIFICATIONS & LICENSES:
- Society of Clinical Research Associates or Association of
Clinical Research Professionals certification is preferred. May
require a valid California Driver's License.
- Frequently stand, walk, twist, bend, stoop, squat and use fine
- Occasionally sit, reach above shoulders, perform desk based
computer tasks, use a telephone and write by hand, lift, carry,
push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and
file paperwork or parts, rarely lift, carry, push, and pull objects
that weigh 40 pounds or more.
* - Consistent with its obligations under the law, the University
will provide reasonable accommodation to any employee with a
disability who requires accommodation to perform the essential
functions of his or her job.
- Hybrid (on-site 2-3 days per week; on occasions more)
- Position may at times require the employee to work with or be
in areas where hazardous materials and/or exposure to chemicals,
blood, body fluid or tissues and risk of exposure to contagious
diseases and infections.
- May require extended or unusual work hours based on research
requirements and business needs.
- Interpersonal Skills: Demonstrates the ability to work well
with Stanford colleagues and clients and with external
- Promote Culture of Safety: Demonstrates commitment to personal
responsibility and value for safety; communicates safety concerns;
uses and promotes safe behaviors based on training and lessons
- Subject to and expected to comply with all applicable
University policies and procedures, including but not limited to
the personnel policies and other policies found in the University's
Administrative Guide, http://adminguide.stanford.edu .
As an organization that receives federal funding, Stanford
University has a COVID-19 vaccination requirement that will apply
to all university employees, including those working remotely in
the United States and applicable subcontractors. To learn more
about COVID policies and guidelines for Stanford University Staff,
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Pay Grade: H
- Department URL: http://radiology.stanford.edu/
- Requisition ID: 94357 As an organization that receives federal
funding, Stanford University has a COVID-19 vaccination requirement
that will apply to all university employees, including those
working remotely in the United States and applicable
subcontractors. To learn more about COVID policies and guidelines
for Stanford University Staff, please visit
Keywords: Stanford Medicine, Santa Clara , Senior Clinical Research Coordinator and Project Manager, Healthcare , Santa Clara, California
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